Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-02-25 @ 11:05 PM
Study NCT ID:
NCT01566812
Status:
UNKNOWN
Last Update Posted:
2017-03-07
First Post:
2012-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Breastfeeding Optimization on Early Vascular Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-05', 'studyFirstSubmitDate': '2012-03-27', 'studyFirstSubmitQcDate': '2012-03-27', 'lastUpdatePostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular risk', 'timeFrame': '5 years', 'description': 'Abdominal aortic/carotid intima media thickness, distensibility, elastic modulus; pulse wave velocity, stiffness index, blood pressure; echocardiography: ejection fraction (%), fractional shortening (%), TAPSE (cm), cardiac index (L/min/m2), LV mass (grams)'}, {'measure': 'Breastfeeding habits', 'timeFrame': '1 years', 'description': 'Breastfeeding practice: Y/N, night/day, frequency (time interval between breastfeeding, e.g 2 hours) Supplementary formula: frequency/day, volume per feeding Complementary feeding: Y/N, type of foods; frequency/day Employer and employee satisfaction'}], 'secondaryOutcomes': [{'measure': 'Child growth', 'timeFrame': '5 years', 'description': 'Body weight, height, head circumference, abdominal circumference'}, {'measure': 'Lung function', 'timeFrame': '5 years', 'description': 'Resistance, compliance, time constant, FVC (liters), FEV1 (liters) measured by spirometry'}, {'measure': 'Microbiome', 'timeFrame': '1 years', 'description': 'Infant nasopharyngeal \\& oral flora, digestive tract/feces flora, maternal oropharyngeal evaluated using PCR and culture.'}, {'measure': 'Development', 'timeFrame': '5 years', 'description': 'Bayley Infant Scales, IQ'}, {'measure': 'Illness', 'timeFrame': '1 year', 'description': 'Infection/fever, allergic symptoms, wheezing, upper/lower respiratory disease, gastrointestinal symptoms'}, {'measure': 'Inflammation', 'timeFrame': '1 year', 'description': 'Serum hs-CRP, Fibrinogen'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast Feeding', 'Cardiovascular Risk'], 'conditions': ['Breast Feeding', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '27250730', 'type': 'DERIVED', 'citation': 'Savitri AI, Idris NS, Indawati W, Saldi SR, Amelia D, Baharuddin M, Sastroasmoro S, Grobbee DE, Uiterwaal CS. BReastfeeding Attitude and Volume Optimization (BRAVO) trial: study protocol for a randomized controlled trial. Trials. 2016 Jun 2;17(1):271. doi: 10.1186/s13063-016-1397-y.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to find out whether breast feeding optimization will increase breast feeding rates and to evaluate its effect on cardiovascular risk and general health of children.', 'detailedDescription': "Breast feeding is suggested to give many benefits for babies and there are some initial prove that it might affect their future health, including the development of cardiovascular diseases. In Indonesia, breast feeding rates are very low, while there is a strong upsurge of cardiovascular disease. In this study, we propose to randomly allocate pregnant Indonesian women who plan to give breast feeding for no more than two months, to either care as usual or to a breast feeding empowerment program lasting to 6 months post partum. At the age of one year, all randomized offspring will undergo non-invasive echographic aortic vascular measurements and cardiovascular risk profiling. Measurements for assessing children's general health status will also be performed, including growth monitoring, repeated lung function test, and microbiomic sampling."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n* Plan to breast feed for ≤2 months\n* Residing in vicinity ≤ 5 km from the hospital/agree to comply to health visit schedule\n* Telephone communication is possible\n* No known HIV or active tuberculosis in mother\n* Uncomplicated pregnancy'}, 'identificationModule': {'nctId': 'NCT01566812', 'acronym': 'BRAVO', 'briefTitle': 'Effect of Breastfeeding Optimization on Early Vascular Development', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'BReast Feeding Attitude and Volume Optimization (BRAVO) Trial: A Randomized Breast Feeding Optimization Experiment', 'orgStudyIdInfo': {'id': 'BRAVO_trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breast feeding optimization', 'interventionNames': ['Behavioral: Breast feeding optimization', 'Behavioral: Usual care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual/routine care', 'interventionNames': ['Behavioral: Usual care']}], 'interventions': [{'name': 'Breast feeding optimization', 'type': 'BEHAVIORAL', 'description': 'Breast feeding optimization program extends from late pregnancy period to 6 months after birth. Prenatal intervention consists of individual and group counseling/education; perinatal intervention consists of in-hospital lactation support; postnatal intervention consists of home visit, counseling session, reminding telephone call and bulk SMS, special counseling for working mothers, breast pump rental, occupational-related support', 'armGroupLabels': ['Breast feeding optimization']}, {'name': 'Usual care', 'type': 'BEHAVIORAL', 'description': 'Usual care applied in the hospital', 'armGroupLabels': ['Breast feeding optimization', 'Usual/routine care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Budi Kemuliaan Hospital', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'overallOfficials': [{'name': 'Nikmah S Idris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}, {'name': 'Cuno SPM Uiterwaal, Ass Prof, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Julius Center'}, {'name': 'Sudigdo Sastroasmoro, Prof, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CEEBM, University of Indonesia'}, {'name': 'Rulina Suradi, MD, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Indonesia University'}, {'name': 'Diederick E Grobbee, Prof, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Julius Center'}, {'name': 'Mohammad Baharuddin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Budi Kemuliaan Hospital'}, {'name': 'Debby Bogaert, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Utrecht University'}, {'name': 'Annemieke MV Evelein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Julius Center'}, {'name': 'Wahyuni Indawati, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'CEEBM', 'class': 'UNKNOWN'}, {'name': 'Julius Center', 'class': 'OTHER'}, {'name': 'Budi Kemuliaan Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Nikmah Salamia Idris', 'investigatorAffiliation': 'Indonesia University'}}}}